FDA Lifts Hold On Blueprint’s CDK2 Inhibitor Trial, Potentially Calming Nerves
The FDA placed a partial hold in February amid ocular adverse event concerns, but soon lifted it. Other CDK2 inhibitors have had ocular toxicity issues as well.
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The FDA placed a partial hold on the VELA study of BLU-222 due to some patients experiencing visual toxicity, but the company anticipates reporting data and said it is near identifying Phase II dose.
Analysts had forecast Q4 Roctavian sales of $5m-$6m, but they came in shy of $3m, and uptake has not yet come to reflect apparent demand.
After sales of the RET inhibitor have been commercially disappointing, Blueprint said it is selling US rights to the drug to Rigel for $15m up front and potentially more than $100m in milestones.